Method of reducing reactogenicity induced by administration of vaccine or immunogenic composition

Abstract

The invention provides a pro-resolving mediator for use in the reduction of reactogenicity induced by administration of a vaccine or immunogenic composition comprising at least an antigen, and vaccines or immunogenic compositions comprising such a pro-resolving mediator.

The invention claimed is: 
     
       1. A method of reducing reactogenicity induced by administration of a vaccine or immunogenic composition comprising at least one antigen, said method comprising:
 administering a pro-resolving mediator, which is separate from said vaccine or immunogenic composition, wherein said pro-resolving mediator is administered before, concurrently with, or after the administration of a vaccine or immunogenic composition comprising an antigen and an adjuvant selected from the group consisting of an oil-in-water emulsion, liposomes, a saponin, a TLR4 (toll-like receptor 4) agonist and ISCOMS (immune stimulating complexes), or any combination of two or more thereof, 
 wherein the pro-resolving mediator is selected from the group consisting of: a resolvin (E-series or D-series), a maresin, a lipoxin, and a protectin, or any combination of two or more thereof, and 
 wherein the pro-resolving mediator promotes resolution of the inflammatory response, thereby reducing reactogenicity. 
 
     
     
       2. The method of  claim 1 , wherein the pro-resolving mediator is selected from the group consisting of: Resolvin E1, Resolvin E2, Resolvin E3, Resolvin D1, Resolvin D2, Resolvin D3, Resolvin D4, 7-Maresin-1, protectin D1/neuroprotectin D1, 17-hydroxydocosahexaenoic acid, lipoxin A 4  or any combination of two or more thereof. 
     
     
       3. The method of  claim 1 , wherein the pro-resolving mediator is administered 5, 10, 20, 30, 45 minutes or more, or 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 hours or more before administration of the vaccine or immunogenic composition. 
     
     
       4. The method of  claim 1 , wherein the pro-resolving mediator is administered 5, 10, 20, 30, 45 minutes or more, or 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 hours or more after administration of the vaccine or immunogenic composition. 
     
     
       5. The method of  claim 1 , wherein the pro-resolving mediator is administered by the same route as the vaccine or immunogenic composition. 
     
     
       6. The method of  claim 1 , wherein the pro-resolving mediator is administered by a different route as the vaccine or immunogenic composition. 
     
     
       7. The method of  claim 1 , wherein the pro-resolving mediator is administered orally, sublingually, intramuscularly, intradermally or transdermally. 
     
     
       8. The method of  claim 6 , wherein the pro-resolving mediator is administered at the same site as the vaccine or immunogenic composition. 
     
     
       9. The method of  claim 8 , wherein the vaccine or immunogenic composition is delivered intramuscularly or intradermally, and wherein the pro-resolving mediator is delivered transdermally. 
     
     
       10. The method of  claim 1 , wherein the adjuvant is a saponin and/or a TLR4 (toll-like receptor 4) agonist. 
     
     
       11. The method of  claim 1 , wherein the antigen is selected from the group consisting of: a whole-organism, a polypeptide, a polysaccharide, a peptide, a nucleic acid and a protein-polysaccharide conjugate, or any combination of two or more thereof. 
     
     
       12. The method of  claim 1 , wherein said adjuvant is an oil-in-water emulsion. 
     
     
       13. The method of  claim 10 , wherein the saponin is obtained from a Quil A fraction. 
     
     
       14. The method of  claim 1 , wherein the adjuvant is QS21. 
     
     
       15. The method of  claim 10 , wherein the TLR4 agonist is a detoxified lipopolysaccharide. 
     
     
       16. The method of  claim 15 , wherein the detoxified-lipopolysaccharide is 3D-MPL. 
     
     
       17. The method of  claim 10 , wherein the saponin and/or TLR4 agonist is in a liposomal formulation. 
     
     
       18. The method of  claim 10 , wherein the saponin is QS21. 
     
     
       19. The method of  claim 10 , wherein the pro-resolving mediator is administered before the administration of the vaccine or immunogenic composition. 
     
     
       20. The method of  claim 10 , wherein the pro-resolving mediator is administered concurrently with the administration of the vaccine or immunogenic composition. 
     
     
       21. The method of  claim 10 , wherein the pro-resolving mediator is administered after the administration of the vaccine or immunogenic composition.